(104 days)
No
The device description and performance studies indicate a standard lateral flow immunoassay, which does not involve AI or ML for result interpretation or analysis. The results are qualitative and based on visual detection of lines.
No.
The device is an in vitro diagnostic test designed to detect the presence of drugs in human urine. It is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the qualitative detection of ... drugs in human urine," indicating its use in identifying substances within the body. Furthermore, the descriptions for various test types (e.g., Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests) clearly state, "It is an in vitro diagnostic device" or "The test is for in vitro diagnostic use only," which directly designates it as a diagnostic device.
No
The device is described as a rapid lateral flow immunoassay in Dip Card or Cup formats, which are physical, hardware-based tests for in vitro diagnostic use. The summary does not mention any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Device Description" explicitly states: "The tests are single-use, in vitro diagnostic devices..."
Furthermore, the "Intended Use / Indications for Use" sections for the Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests and Cup Tests both state: "The test is for in vitro diagnostic use only."
N/A
Intended Use / Indications for Use
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Conc. (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKZ, DIS, JXM, DIO, DJC, LDJ, LAF, DJR, DNK, LCM, JXN, LFG
Device Description
The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Method Comparison (Accuracy) Studies: Chemtrue® Drug Screen FYL/TML Tests were compared to the LC/MS Reference Method. The accuracy of the Chemtrue® Test devices were evaluated against one hundred and seventy-six (176) clinical urine specimens. Each specimen was confirmed with LC/MS assay with the value assignment. Ninety-three (93) Fentanyl clinical urine specimens and eighty-three (83) Tramadol urine specimens in blind-code label were tested in this correlation study against the LC/MS reference method. Four (4) operators performed the tests. One drug analyst with one set of blind code in one device format - Dip Card / Cup were tested by one operator. Each blind-labeled sample was randomly distributed to each operator for each device format by the Clinical Research Cooperator.
OTC Lay-user Accuracy Studies: One hundred and forty (140) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup) for OTC accuracy and usability study from three (3) intended user sites (Shopping Mall, School and Hotel) with LC/MS confirmed urine sample concentrations are consisted of no drug present (0), 50%, 75%, 125% and 150% of the cutoff by spiking drugs into drug-free urine pool. Each sample was aliquot into an individual blind-labeled container. Each lay-user was provided with a package insert in English only and two (2) random blind-coded samples with one each of the device format.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Precision/ Reproducibility Studies:
Precision/reproducibility studies were carried out for Norfentanyl and Tramadol spiked urine controls with LC/MS confirmed concentrations of 0%, -50%, 100%, +25% and +50% of the drug cut-off. All the aliquots were blindly coded by the research coordinator who prepared the samples and didn't perform the testing. These blind coded samples were used for FYLS and TML100 tests in Cup and Dip Card formats in a randomized order. Five (5) replicates at each control level were tested with three (3) lots each device format of FYL and TML Drug Screen Cup/Dip Card Tests by each of the three operator tested the blind-labeled samples according to proposed package inserts, record the test results and sign on the data collection form. The study was performed in five (5) consecutive days. -
Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen.
The following structurally-related compounds were tested for cross-reactivity and found to be positive if the levels were greater than the following listed concentrations:
Norfentanyl 5 related compounds; Tramadol 100 related compounds. -
Interference: Following potential interferents were tested with one lot each of the test device format. It was confirmed not to cross-react, when tested at concentrations of 100 µg/mL at ±25% of the drug cutoff concentrations: Endogenous Compounds and Structurally unrelated compounds.
The following compounds showed no interference at the concentrations below: Acetylsalicylic Acid, 7-Aminoflunitrazepam, Bupropion, Caffeine, Carbamazepine, Lorazepam Glucuronide, LSD, Metformin, Norpseudoephedrine, Oxazepam Glucuronide, Sufentanil Citrate, 11-nor-9 carboxy THC, L-thyroxine, Zolpidem Tartrate.
Further testing with the following opioids compounds /drugs at a concentration of 100 ug/mL in ±25% of the cutoff drug urine controls confirm that no interference or crossreactivity was observed: 6-Acetylmorphine, Amphetamine, Amphetamine, Codeine, Dihydrocodeine, EDDP, Fluoxetine, Heroin, Hydrocodone, Hydromorphone, Levorphanol, Methadone, Morphine, Morphine-3-glucuronide, Naloxone, Norbuprenorphine, Norcodeine, Norketamine, Normorphine, Noroxycodone, Oxycodone, Oxymorphone, Pentazocine (Talwin), Tramadol.
The following opioids compounds /drugs do not interfere or cross-react at a concentration of 10 ug/mL in ±25% of the cutoff drug urine controls: Meperidine, Normeperidine, Risperidone.
Usability Interference Study: The drug tests were tested with each of the drug analytes at 150% and 50% of the drug cut-off urine samples. Results demonstrate no interference or cross reactivity among the 17 drug tests of the Chemtrue® Drug Screen Tests, when testing 50% of the drug cut off and no false positive results. When testing with 150% of the drug cut off urine samples, only the targeted drug tests presented positive results, including the class-drug clinical samples, such as BAR, BZO and TCA that contain multiple drugs in the drug class. No false negative or false positive results were observed. -
Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.010, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results.
-
Stability Study: To establish and support the shelf life and expiration date, stability studies were conducted under accelerated temperature (at 60°C, 50°C and 40°C), and real time (2°C to 30°C) with three (3) lots of each device format. The stability study results support two (2) years shelf life of the products at (2℃ to 30℃). The real time stability study is still on going.
To validate robustness of the Chemtrue® Drug Screen FYL/TML Test devices, studies were conducted after the devices (Cup and Dip Card Tests) were exposed to various lighting, humidity and temperature conditions. The results support the robustness of the Chemtrue® Devices. -
Method Comparison (Accuracy) Studies:
The accuracy of the Chemtrue® Test devices were evaluated against one hundred and seventy-six (176) clinical urine specimens confirmed with LC/MS assay.
Key Results: The percent agreement for FYL 5 (Dip Card) was 100% (+) and 93.4% (-). For TML100 (Dip Card), it was 100% (+) and 100% (-). For FYL5 (Cup), it was 100% (+) and 95% (-). For TML100 (Cup), it was 100% (+) and 100% (-). -
OTC Lay-user Accuracy Studies:
Sample Size: 140 intended lay-users participated for each device format.
Key Results: The results demonstrate that the agreement between the Chemtrue® Drug Screen FYL/TML test devices and LC/MS assayed values is 100%. Over 92% of the lay users can easily follow the instructions to perform the test and interpret the results. A Flesch-Kincaid reading analysis supports a 7th grade reading level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy and agreement values are provided as percentages, but not detailed sensitivity, specificity, PPV, NPV.)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Chemtron Biotech, Inc. Jane Zhang Vice President of Quality 9245 Brown Deer Road, Suite B San Diego, California 92121
Re: K232736
Trade/Device Name: Chemtrue® Drug Screen Fentany]/Tramadol Cup Test. Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test. Chemtrue® Multi-Panel Drug Screen Dip Card Test. Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKZ, DIS, JXM, DIO, DJC, LDJ, LAF, DJR, DNK, LCM, JXN, LFG Dated: November 16, 2023 Received: November 17, 2023
Dear Jane Zhang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Joseph Joseph A. Kotarek -S Date: 2023.12.20 10:46:07 -05'00' Joseph Kotarek Branch Chief Toxicology Branch Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232736
Device Name
Device Name: Chemtrue® Drug Screen Multi-Panel Dip Card Tests
Indications for Use (Describe)
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Conc. (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
3
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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4
Indications for Use
510(k) Number (if known) K232736
Device Name
Device Name: Chemtrue® Drug Screen Multi-Panel Cup Tests
Indications for Use (Describe)
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentaryl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Conc. (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
5
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K232736
Device Name
Device Name: Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests
Indications for Use (Describe)
The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|-------------|--------------|-------------|---------------------------------|
| Norfentanyl | FYL | Norfentanyl | 5 |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
==============================================================================================================================================================================
7
Indications for Use
510(k) Number (if known) K232736
Device Name
Device Name: Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests
Indications for Use (Describe)
The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|-------------|--------------|-------------|---------------------------------|
| Norfentanyl | FYL | Norfentanyl | 5 |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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8
510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
A. SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA
- USA.
TEL: 858-450-0044:
FAX: 858-450-0046
Contact Person: Jane Zhang, Vice President of Quality Official FDA Correspondent
9245 Brown Deer Road, Suite B San Diego, CA 92121
Office: (858) 450-0044; FAX: (858) 450-0046
Email: jane(@uschemtronbio.com
Date: September 06, 2023
B. DEVICE
Trade or Proprietary Name: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test,
Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test,
Chemtrue® Multi-Panel Drug Screen Cup Test,
Chemtrue® Multi-Panel Drug Screen Dip Card Test.
Common Name: Single/Multi-Drugs of Abuse Screen Urine Tests
Regulatory Class: Class II
Regulatory Information:
| Drug of Abuse | Product Code | Panel | Regulation Section |
|---|---|---|---|
| Fentanyl (FYL) | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate test system. |
| Tramadol (TML) | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate test system. |
These devices also incorporate the assays previously cleared under 510(k) numbers K153192 and K142396, which consist of any combinations of the following drug tests:
| Drug of Abuse | Product
Code | Panel | Regulation Section |
|---------------------|-----------------|---------------|------------------------------------------------------|
| Amphetamine | DKZ | Toxicology 91 | 21CFR 862.3100, Amphetamine Test System |
| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
| Buprenorphine (BUP) | DJG | Toxicology 91 | 21CFR 862.3650, Opiate Test System |
| Cocaine | DIO | Toxicology 91 | 21 CFR 862.3250, Cocaine and metabolites Test System |
| Ecstasy (MDMA) | DJC | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Marijuana | LDJ | Toxicology 91 | 21 CFR 862.3870, Cannabinoids Test System |
| Methamphetamine | LAF | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Methadone | DJR | Toxicology 91 | 21 CFR 862.3620, Methadone Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
| Opiates | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Oxycodone | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
9
| Phencyclidine | LCM | Toxicology 91 | Unclassified, Enzyme immunoassay Phencyclidine |
|---|---|---|---|
| Propoxyphene | JXN | Toxicology 91 | 21 CFR 862.3700 Propoxyphene test system |
| Tricyclic Antidepressants (TCA) | LFG | Toxicology 91 | 21 CFR 862.3910, Tricyclic antidepressant drugs test system. |
C. PREDICATE DEVICES
K153192: Chemtrue® Multi-Panel Drug Screen Cup/Dip Card Tests
D. INDICATIONS FOR USE:
The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Norfentanyl (FYL) 5 and Tramadol (TML) 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and calibrators are listed below:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|-------------|--------------|-------------|---------------------------------|
| Norfentanyl | FYL | Norfentanyl | 5 |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentany// Tramadol. The test is for in vitro diagnostic use only.
The Chemtrue® Drug Screen Fentany] / Tramadol Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Norfentany] (FYL) 5 and Tramadol (TML) 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and calibrators are listed below:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| (ng/mL) | |||
| Norfentanyl | FYL | Norfentanyl | 5 |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only.
10
The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|---------------------------|--------------|-----------------------------------|---------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamin | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.
The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants.
The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone,
11
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|---------------------------|--------------|-----------------------------------|---------------------------------|
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamin | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.
The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.
E. DEVICE DESCRIPTION
The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.
ட் SUBSTANTIAL EQUIVALENCE INFORMATION:
12
| Item | Device | Predicate - K153192 |
|---|---|---|
| Indication(s) for Use | Same | Qualitative determination of drugs of abuse in human urine. |
| Specimen Type | Same | Human urine |
| Type of Test | Same | Qualitative test of in vitro diagnostic device |
| Methodology /Technological | ||
| Characteristics | Same | Lateral flow, antibody and antigen competitive binding qualitative |
| immunoassay. | ||
| Configurations | Same | Cup and Dip Card |
| Storage | Same | 2 - 30°C |
Comparison with the predicate devices is outlined below:
| Item | Candidate Device | Differences | ||||||
|---|---|---|---|---|---|---|---|---|
| Predicate - K153192 | ||||||||
| Calibrator | ||||||||
| /Cut Off | Norfentanyl 5 ng/mL | |||||||
| Tramadol 100 ng/mL | AMP at | |||||||
| 300/500/ | ||||||||
| 1000 ng/mL | BAR at | |||||||
| 200/ 300 | ||||||||
| ng/mL | BZO at | |||||||
| 200/ 300 | ||||||||
| ng/mL | BUP at | |||||||
| 10 ng/mL | COC at | |||||||
| 150/300 | ||||||||
| ng/mL | MDMA | |||||||
| at 500 | ||||||||
| ng/mL | MET at | |||||||
| 300/500/ | ||||||||
| 1000 ng/mL | ||||||||
| MTD at | ||||||||
| 300 ng/mL | MOR at | |||||||
| 300 ng/mL | OPI at | |||||||
| 2000 ng/mL | OXY at | |||||||
| 100 ng/mL | PCP at | |||||||
| 25 ng/mL | PPX at | |||||||
| 300 ng/mL | TCA at | |||||||
| 1000 ng/mL | ||||||||
| THC at 50 ng/mL |
G. TEST PRINCIPLE
These devices are rapid lateral flow immunoassays in which chemically modified drugs (drugprotein conjugates) compete with drugs that may be present in urine. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cutoff concentration, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibodycolloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.
A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.
Monoclonal anti-drug antibodies that are used on the Fentanyl and Tramadol Test devices are derived from mouse.
13
H. PERFORMANCE CHARACTERISTICS
Performance data of AMP300/500, BAR200, BZO200, COC150, MET300/500 and PPX were presented in the cleared 510(k) K153192 submission. AMP1000, BAR3000, BZO300, BUP10, COC300, MET1000, MOR, PCP, THC, MDMA, MTD, OPI2000, OXY and TCA analytes were previously cleared under K143599 and K142396. In this submission, Fentanyl (FYL) and Tramadol (TML) study data are summarized and presented below:
-
- Precision/ Reproducibility Studies:
Precision/reproducibility studies were carried out for Norfentanyl and Tramadol spiked urine controls with LC/MS confirmed concentrations of 0%, -50%, 100%, +25% and +50% of the drug cut-off. All the aliquots were blindly coded by the research coordinator who prepared the samples and didn't perform the testing. These blind coded samples were used for FYLS and TML100 tests in Cup and Dip Card formats in a randomized order. Five (5) replicates at each control level were tested with three (3) lots each device format of FYL and TML Drug Screen Cup/Dip Card Tests by each of the three operator tested the blind-labeled samples according to proposed package inserts, record the test results and sign on the data collection form. The study was performed in five (5) consecutive days. The data is analyzed and summarized in the tables below:
- Precision/ Reproducibility Studies:
| Lot No. | 0 | -50%
Cut off | -25%
Cut off | Cut Off | +25%
Cut off | +50%
Cut off |
|------------------------------------------------|--------|-----------------|-----------------|---------|-----------------|-----------------|
| Lot 1 | 10-/0+ | 10-/0+ | 10-/0+ | 8+/2- | 10+/0- | 10+/0- |
| Lot 2 | 10-/0+ | 10-/0+ | 10-/0+ | 9+/1- | 10+/0- | 10+/0- |
| Lot 3 | 10-/0+ | 10-/0+ | 10-/0+ | 8+/2- | 10+/0- | 10+/0- |
| SUM | 30-/0+ | 30-/0+ | 30-/0+ | 25+/5- | 30+/0- | 30+/0- |
| Table 1b. TML Dip Card Test: Cutoff: 100 ng/mL | | | | | | |
| Lot No. | 0 | -50%
Cut off | -25%
Cut off | Cut Off | +25%
Cut off | +50%
Cut off |
| Lot 1 | 10-/0+ | 10-/0+ | 10-/0+ | 9+/1- | 10+/0- | 10+/0- |
| Lot 2 | 10-/0+ | 10-/0+ | 10-/0+ | 7+/3- | 10+/0- | 10+/0- |
| Lot 3 | 10-/0+ | 10-/0+ | 10-/0+ | 9+/1- | 10+/0- | 10+/0- |
| SUM | 30-/0+ | 30-/0+ | 30-/0+ | 25+/5- | 30+/0- | 30+/0- |
| Table 1c. FYL Cup Test: Cutoff: 5 ng/mL | | | | | | |
| Lot No. | 0 | -50%
Cut off | -25%
Cut off | Cut Off | +25%
Cut off | +50%
Cut off |
| Lot 1 | 10-/0+ | 10-/0+ | 10-/0+ | 9+/1- | 10+/0- | 10+/0- |
| Lot 2 | 10-/0+ | 10-/0+ | 10-/0+ | 9+/1- | 10+/0- | 10+/0- |
| Lot 3 | 10-/0+ | 10-/0+ | 10-/0+ | 8+/2- | 10+/0- | 10+/0- |
| SUM | 30-/0+ | 30-/0+ | 30-/0+ | 26+/4- | 30+/0- | 30+/0- |
| Table 1d. TML Cup Test: Cutoff: 100 ng/mL | | | | | | |
| Lot No. | 0 | -50%
Cut off | -25%
Cut off | Cut Off | +25%
Cut off | +50%
Cut off |
Table 1a. FYL Dip Card Test: Cutoff: 5 ng/mL
14
| Lot 1 | 10-/ 0+ | 10-/ 0+ | 10-/ 0+ | 9+/ 1. | 10+/ 0- | 10+/ 0- |
|---|---|---|---|---|---|---|
| Lot 2 | 10-/ 0+ | 10-/ 0+ | 10-/ 0+ | 7+/ 3- | 10+/ 0- | 10+/ 0- |
| Lot 3 | 10-/ 0+ | 10-/ 0+ | 10-/0+ | 8+/ 2. | 10+/ 0- | 10+/ 0- |
| SUM | 30-/ 0+ | 30-/ 0+ | 30-/ 0+ | 24+/ 6- | 30+/ 0- | 30+/ 0- |
-
- Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen.
The following structurally-related compounds were tested for cross-reactivity and found to be positive if the levels were greater than the following listed concentrations:
- Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen.
Norfentanyl 5 related compounds:
| Substances | Concentration ng/mL | % Cross Reactivity |
|---|---|---|
| Norfentanyl | 5 | 100 |
| Fentanyl | 10 | 100 |
| 4-Fluoro-isobutyryl Fentanyl | >20,000 | 10,000 |
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
17
| # of "+" Results | # of "-" Results | Number of "-" | # of "+" Results | # of "-" | |
|---|---|---|---|---|---|
| from the targeted | from the targeted | results from the | from the targeted | Results | |
| drug test strips | drug test strips | other test strips | drug test strips | from the other | |
| test strips | |||||
| FYL 5 | |||||
| Calibrator Norfentanyl 5 | 0 | 12 | 180 | 12 | 180 |
| TML 100 calibrator Tramadol | 0 | 12 | 180 | 12 | 180 |
| AMP 300/500/1000 d-Amphetamine | 0 | 36 | 270 | 36 | 270 |
| BAR 300 Calibrator Pentobarbital | 0 | 12 | 180 | 12 | 180 |
| Calibrator Secobarbital | 0 | 12 | 180 | 12 | 180 |
| BAR200 3 clinical samples test data | N/A | 0 | 0 | 12 | 180 |
| BZO300: Calibrator Oxazepam | 0 | 12 | 180 | 12 | 180 |
| BZO200: 2 clinical samples test data | N/A | 0 | 0 | 8 | 120 |
| TCA 1000 Calibrator Nortripytline | 0 | 12 | 180 | 12 | 180 |
| 4 clinical samples test data | N/A | 0 | 0 | 16 | 240 |
| COC150/300 Calibrator Benzoylecgonine | 0 | 24 | 360 | 12 | 180 |
| BUP 10 Calibrator Buprenophine | 0 | 12 | 180 | 12 | 180 |
| MDMA500 Calibrator d,1- | |||||
| Methylenedioxymethamphetamine | 0 | 12 | 180 | 12 | 180 |
| MTD 300 Calibrator Methadone | 0 | 12 | 180 | 12 | 180 |
| MOR300/OPI2000 Calibrator Morphine | 0 | 12 | 180 | 12 | 180 |
| PPX 300 Calibrator Propoxyphene | 0 | 12 | 180 | 12 | 180 |
| MET300/500/1000 d-Methamphetamine | 0 | 36 | 270 | 36 | 270 |
| OXY100 Calibrator Oxycodone | 0 | 12 | 180 | 12 | 180 |
| PCP 25 Calibrator Phencyclidine | 0 | 12 | 180 | 12 | 180 |
| THC50 Calibrator 11-nor-A°-THC9-COOH | 0 | 12 | 180 | 12 | 180 |
| SUBTOTAL | 0 | 246 | 3,420 | 288 | 3,780 |
| TOTAL | 3,672 | 4,068 |
CONCLUSION: The usability interference study results demonstrate that no interference or cross reactivity among the 17 drug tests of the Chemtrue® Drug Screen Tests, when testing 50% of the drug cut off. No false positive result was presented. When testing with 150% of the drug cut off urine samples, only the targeted drug tests presented positive results, including the class-drug clinical samples, such as BAR, BZO and TCA that contain multiple drugs in the drug class. No false negative or false positive results were observed.
-
- Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.010, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results.
-
- Stability Study: To establish and support the shelf life and expiration date, stability studies were conducted under accelerated temperature (at 60°C, 50°C and 40°C), and real time (2°C to 30°C) with three (3) lots of each device format. The stability study results support two (2) years shelf life of the products at (2℃ to 30℃). The real time stability study is still on going.
18
To validate robustness of the Chemtrue® Drug Screen FYL/TML Test devices, studies were conducted after the devices (Cup and Dip Card Tests) were exposed to various lighting, humidity and temperature conditions. The results support the robustness of the Chemtrue® Devices.
-
- Method Comparison (Accuracy) Studies:
Chemtrue® Drug Screen FYL/TML Tests were compared to the LC/MS Reference Method. The accuracy of the Chemtrue® Test devices were evaluated against one hundred and seventy-six (176) clinical urine specimens. Each specimen was confirmed with LC/MS assay with the value assignment. Ninety-three (93) Fentanyl clinical urine specimens and eighty-three (83) Tramadol urine specimens in blind-code label were tested in this correlation study against the LC/MS reference method. Four (4) operators performed the tests. One drug analyst with one set of blind code in one device format - Dip Card / Cup were tested by one operator. Each blind-labeled sample was randomly distributed to each operator for each device format by the Clinical Research Cooperator. The results are summarized in the tables below:
- Method Comparison (Accuracy) Studies:
| ChemtrueⓇ
Drug Screen
Dip Card | | Concentration By LC/MS (ng/mL) | | | %
Agreement | | |
|--------------------------------------|-----|--------------------------------|--------------------|-----------------------------|------------------------------------------------------------|------------------------------------------------|-------|
| | | (-) Negative | | | | | |
| | | No drug
present | 150% of the
cutoff) | |
| FYL 5 | (+) | 0 | 1 | 3 | 6 | 26 | 100% |
| | (-) | 22 | 29 | 6 | 0 | 0 | 93.4% |
| TML100 | (+) | 0 | 0 | 0 | 8 | 23 | 100% |
| | (-) | 20 | 20 | 12 | 0 | 0 | 100% |
Table 6a. Method comparison study summary: Chemtrue® Drug Screen Dip Card Test results vs LC/MS
Table 6b. Method comparison study summary - Chemtrue® Drug Screen Cup Test results vs LC/MS
| Chemtrue®
Drug Screen
| Cup | Concentration By LC/MS (ng/mL) | % Agreement | ||||
|---|---|---|---|---|---|---|
| No drug present | (-) | |||||
| 150% of the C/O) | ||||||
| FYL5 (+) | 0 | 1 | 2 | 6 | 26 | 100% |
| FYL5 (-) | 22 | 29 | 7 | 0 | 0 | 95% |
| TML100 (+) | 0 | 0 | 0 | 8 | 23 | 100% |
| TML100 (-) | 20 | 20 | 12 | 0 | 0 | 100% |
DISCORDANT RESULTS:
| Cutoff Value (ng/mL) | Analyte assay
(POS/NEG) | Drug Analyte | LC/MS Value
(ng/mL) |
|-----------------------------|----------------------------|--------------|------------------------|
| Norfentanyl 5 Cup Test | + | Norfentanyl | 3.38 |
| Norfentanyl 5 Cup Test | + | Norfentanyl | 2.03* |
| Norfentanyl 5 Cup Test | + | Norfentanyl | 4.94 |
| Norfentanyl 5 Dip Card Test | + | Norfentanyl | 3.38 |
| Norfentanyl 5 Dip Card Test | + | Norfentanyl | 2.03* |
19
| + | Norfentanyl | 3.97 | |
|---|---|---|---|
| + | Norfentanyl | 4.94 |
Five (5) discordant results were at or near the norfentanyl drug cutoff level of 5 ng/mL. One sample (it was tested with one Cup and one Dip Card device to present two test data) with a norfentanyl concentration of 2.03 ng/mL and Fentanyl concentration of 15.43 ng/ml returned a posstive result. Further analysis indicated that the cross-reactive level of Fentanyl is 10 ng/ml. So the positive result could have been caused by the high concentration of Fentanyl in the urine sample.
-
- OTC Lay-user Accuracy Studies:
One hundred and forty (140) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup) for OTC accuracy and usability study from three (3) intended user sites (Shopping Mall, School and Hotel) with LC/MS confirmed urine sample concentrations are consisted of no drug present (0), 50%, 75%, 125% and 150% of the cutoff by spiking drugs into drug-free urine pool. Each sample was aliquot into an individual blind-labeled container. Each lay-user was provided with a package insert in English only and two (2) random blind-coded samples with one each of the device format. The results are summarized in tables below:
- OTC Lay-user Accuracy Studies:
| Chemtrue®
Drug Screen Dip
Card Test | No Drug
Present | Concentrations By LC-MS/MS (ng/mL) | | | %
Agreement | |
|-------------------------------------------|--------------------|------------------------------------|---------------------------------------------|----------------------------------------------|-------------------------------|------|
| | | (-) | (+) | | | |
| | | Negative
(50% of the C/O) | Near cutoff
Negative
(75% of the C/O) | Near cutoff
Positive
(125% of the C/O) | Positive
(150% of the C/O) | |
| FYL 5 (+) | 0 | 0 | 0 | 24 | 23 | 100% |
| FYL 5 (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| TML 100 (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| TML 100 (-) | 93 | 24 | 24 | 0 | 0 | 100% |
Table 7a. OTC Accuracy study summary between Chemtrue® Dip Card Tests and the LC/MS values
Table 7b. OTC Accuracy study summary between Chemtrue® Cup Tests and the LC/MS values
| Chemtrue®
Drug Screen Cup
Test | Concentrations By LC/MS (ng/mL) | | | | | %
Agreement |
|--------------------------------------|---------------------------------|------------------------------|---------------------------------------------|----------------------------------------------|-------------------------------|----------------|
| | (-) | | | (+) | | |
| | No Drug
Present | Negative
(50% of the C/O) | Near cutoff
Negative
(75% of the C/O) | Near cutoff
Positive
(125% of the C/O) | Positive
(150% of the C/O) | |
| FYL 5
(+) | 0 | 0 | 0 | 22 | 23 | 100% |
| (-) | 93 | 25 | 24 | 0 | 0 | 100% |
| TML 100
(+) | 0 | 0 | 0 | 24 | 23 | 100% |
| (-) | 93 | 24 | 23 | 0 | 0 | 100% |
The results demonstrate that the agreement between the Chemtrue® Drug Screen FYL/TML test devices and LC/MS assayed values is 100%.
These lay-users were also given surveys on the ease of understanding the package insert instructions. The results demonstrate that over 92% of the lay users can easily follow the instructions to perform the test and interpret the results. A Flesch-Kincaid reading analysis supports a 7th grade reading level.
20
I. CONCLUSION:
Based on the test principle and performance characteristics of the device, it is concluded that the Chemtrue® Drug Screen FYL/TML Test devices are substantially equivalent to the predicate.